Critical Success Factors for Operational Excellence in the Pharmaceutical Industry: Insights from a Qualitative Study

Abstract

AbstractThe paper aims to investigate the Critical Success Factors that exist for Operational Excellence methodology deployment in the Pharmaceutical industry. The research will seek to establish the levels of current Operational Excellence awareness and integration in the Pharmaceutical industry in terms of the deployment of Continuous Improvement methodology. The study involves the analysis of the pros, cons, strengths, weaknesses, and limitations of management commitment for the application to the deployment of Continuous Improvement methodologies in the Pharmaceutical industry. A qualitative methodology was utilised by interviewing a cohort of 28 Pharmaceutical manufacturing Operational Excellence and Continuous Improvement practitioners. The study found that while participants advocated and supported the requirement and importance of Operational Excellence, a key Critical Success Factor identified was senior management support in fostering Operational Excellence culture. A top challenge highlighted for Operational Excellence and Continuous Improvement success, particularly in regulated industries, was a regulatory compliance culture and regulatory bureaucracy. The paper provides a valuable resource for organisations to obtain insight into Critical Success Factors for Continuous Improvement and Operational Excellence and in particular, in a regulated Pharmaceutical manufacturing industry.KeywordsOperational ExcellenceManufacturingContinuous ImprovementPharmaceutical industryLean